NCT04148079

Brief Summary

This study aimed to asses whether physyical therapy (e.g. electrotherapy in the form of low, medium or high frequency currents, massage and kinetotherapy) for treatment of knee osteoarthritis can induce or aggravate certain cardiac diseases during or immediately after therapy. The physyical treatment described is not a new method, is currently used and recommended in all guidelines for non-pharmacological and non-surgical therapy of knee osteoarthritis. What is not clear is whether application of electrotherapy in the knee area can alter the preexisting cardiac condition.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 1, 2019

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

4.4 years

First QC Date

October 29, 2019

Last Update Submit

October 31, 2019

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    Minimal, average, maximum heart rate evaluated by 24 hour Holter EKG monitoring

    Change from Baseline after 10 days

  • Supraventricular, ventricular and total Extrasystoles

    supraventricular, ventricular, total extraystoles evaluated by 24 hour Holter EKG monitoring

    Change from Baseline after 10 days

Interventions

physical therapyOTHER

low frequency currents (galvanic or TENS), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

46 patients, 33 female, 13 male 20 patients had a history of arrythmias (e.g.premature atrial contractions) 19 patients had a history of ischemic heart disease

You may qualify if:

  • clinical diagnosis and imaging diagnosis of knee osteoarthrtitis based on ACR 2000 diagnostic criteria

You may not qualify if:

  • known cardiac arrhythmias (atrial fibrillation, atrial flutter)
  • congestive heart failure class NYHA II, III or IV
  • any other general contraindications for PT (infections, psychiatric disorders etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 29, 2019

First Posted

November 1, 2019

Study Start

March 1, 2013

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

November 4, 2019

Record last verified: 2019-10